Indications and dosages

➣ Growth failure in children with inadequate endogenous GH

Children: 0.16 to 0.24 mg/kg (Genotropin) subcutaneously q week in six or seven divided doses. Or 0.18 mg/kg/week (Humatrope) subcutaneously or I.M., divided equally and given on three alternate days six times weekly (or daily, if epiphyseal closure hasn't occurred). Or 0.024 to 0.034 mg/kg (Norditropin) subcutaneously six or seven times each week using NordiPen injection pen. Or 0.3 mg/kg/week (Nutropin AQ, Nutropin AQ Pen, Tev-Tropin) subcutaneously in equally divided daily doses. Or 0.06 mg/kg (Saizen) subcutaneously or I.M. three times weekly.

➣ Endogenous GH replacement in adults with GH deficiency

Adults: 0.04 mg/kg/week (Genotropin) subcutaneously in six or seven divided doses. Or 0.006 mg/kg/day (Humatrope) subcutaneously. Or initially, no more than 0.006 mg/kg/day (Nutropin AQ, Nutropin AQ Pen, Tev-Tropin) subcutaneously; may increase to a maximum of 0.025 mg/kg daily in patients younger than age 35 or 0.0125 mg/kg/day in patients ages 35 and older. Or 0.005 mg/kg/day (Saizen) subcutaneously; may increase to a maximum of 0.01 mg/kg/day after 4 weeks, depending on patient tolerance.

➣ Short stature related to Turner's syndrome

Children: 0.375 mg/kg/week (Humatrope) subcutaneously, divided into equal doses given on 3 alternate days or daily. Or up to 0.375 mg/kg/week (Nutropin AQ, Nutropin AQ Pen) subcutaneously, divided into equal doses given three or seven times weekly.

Pharmacokinetics

Metabolism and Excretion: Broken down in renal cells to amino acids that are recirculated; some liver metabolism.

Half-life: Subcut—3.8 hr;IM—4.9 hr.

Time/action profile (growth)

ROUTE

ONSET

PEAK

DURATION

IM, subcut

within 3 mo

unknown

12–48 hr

Contraindications/Precautions

Contraindicated in: Closure of epiphyses; Active neoplasia; Hypersensitivity to growth hormone or benzyl alcohol preservative; Acute critical illness (therapy should not be initiated) or respiratory failure; Diabetic retinopathy; Prader-Willi syndrome with obesity and respiratory impairment (risk of fatal complications; can be used only if growth hormone deficiency is documented).

Potential Nursing Diagnoses

Disturbed body image (Indications)

Implementation

Rotate injection sites with each injection.

Saizen: Reconstitute each 5-mg vial with 1–3 mL of bacteriostatic water for injection; use 2–3 mL for 8.8 mg vial. Aim the liquid against glass vial wall. Do not shake; swirl gently to dissolve. Solution is clear; do not use solutions that are cloudy or contain a precipitate. Reconstituted vials are stable for 14 days if refrigerated. To use cool.click needle-free injector, wind the device to energize the spring, and draw medication into the Crystal Check nozzle. Using firm pressure at the injection site, hold the injector at a 90° angle and press the blue actuator button.

Subcutaneous: Injection volume should not exceed 1 mL.

Patient/Family Teaching

Instruct patient and parents on correct procedure for reconstituting medication, site selection, technique for subcut injection, and disposal of needles and syringes. Review dosage schedule. Parents should report persistent pain or edema at injection site.

Explain rationale for prohibition of use for increasing athletic performance. Administration to persons without growth hormone deficiency or after epiphyseal closure may result in acromegaly (coarsening of facial features; enlarged hands, feet, and internal organs; increased blood glucose; hypertension).

Emphasize need for regular follow-up with endocrinologist to ensure appropriate growth rate, to evaluate lab work, and to determine bone age by x-ray exam.

Assure parents and child that these dose forms are synthetic and therefore not capable of transmitting Creutzfeldt-Jakob disease, as was the original somatropin, which was extracted from human cadavers.

Evaluation/Desired Outcomes

Child’s attainment of adult height in growth failure secondary to pituitary growth hormone deficiency. Therapy is limited to period before closure of epiphyseal plates (approximately up to 14–15 yr in girls, 15–16 yr in boys).

The device offers features such as preset dosing that makes the administration of the treatment easier and allows the monitoring of the patients' adherence to Merck Serono's recombinant growth hormone therapy Saizen.

While with Saizen endogenous growth hormone deficiency in children and adults is treated, Merck s ambition is to raise patient compliance to benefit healthcare systems, doctors and most importantly patients.

Merck has tackled this issue head-on with a combination of its recombinant growth hormone (r-hGH) drug Saizen and the related easypod device system.

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